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FDA 510(k)

Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector

K-Number: K163586 · 2017-03-17

Decision Date2017-03-17
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector is the device name listed in this FDA 510(k) record. The listed applicant is Trovrx, Inc. Dba Trovita Health Science. It received FDA 510(k) clearance on 2017-03-17 under 510(k) number K163586. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector?

Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector is a medical device that received FDA 510(k) clearance on 2017-03-17. The listed applicant is Trovrx, Inc. Dba Trovita Health Science. The 510(k) number is K163586.

When did Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector receive FDA 510(k) clearance?

Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector received FDA 510(k) clearance on 2017-03-17, under 510(k) number K163586.

Who is the listed applicant for Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector?

The FDA 510(k) record lists Trovrx, Inc. Dba Trovita Health Science as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector?

The FDA product code for Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector is PIF.

Related Devices (Code: PIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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